ICG Anastomosis Control in Colon Surgery

NCT05981937 | Completed FDA Drug

• 1 other identifier: GREEN COLONIC SAFE ANASTOMOSIS
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This is a parallel monocentric, retrospective cohort study in Guglielmo da Saliceto Hospital, Piacenza, Italy. Aim of this study is to investigate the protective role of Indocyanine green (ICG) for Anastomotic leak (AL) in patients underwent elective segmentary colic resection (transverse colic resection, left colectomy including sigmoidectomy, splenic colic flexure resection). Secondary aims are to detect and to investigate the impact of various risk factors on AL and morbidity and surgical performance within 30 days to surgery.

Conditions

Colon Surgery; Anastomotic Leak

Keywords

ICG; Colon Surgery; Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• Anastomotic leak at 30 days

  Anastomotic leak (a defect of intestinal wall at anastomotic site leading to a communication between the intra- and extraluminal compartments)at 30 days: abdominal CT scan IV and a Clavien Dindo Score ≥III

  30 days

Secondary Outcomes (1)

• Post-operative morbidity

  30 days

Study Arms (2)

Indocyanine Green

Indocyanine green infusion in left-side colorectal surgery (elective segmentary colic resection)

Drug: ICG solution

non-Indocyanine Green

No infusion of Indocyanine green in left-side colorectal surgery (elective segmentary colic resection )

Interventions

ICG solution DRUG

ICG-ATT is available at our institute since 2019 using a near-infrared (NIR) light source and special scope and camera equipped with xenon light (CARL STORZ GmbH \& Co. KG, Tuttlingen, Germany); ICG was supplied as a sterile water-soluble lyophilized powder (Diagnostic Green® GmbH). ICG-ATT is routinely used whenever available in daily practice with the following protocol: after the specimen resection the two colonic stumps or colonic and rectal stumps are checked with 5 cc of ICG 25 mg diluted in 10 cc of water sterile solution before fashioned anastomosis. Two laparoscopes with ICG-optic system are nowadays available department and ICG anastomosis control is always performed if ICG device are available (no performed in case of not available ICG instrument for sterilization in case of two consecutive surgery in the same day, concomitant ICG surgery or ICG malfunction).

Also known as: Indocyanine Green

Indocyanine Green

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A consecutive series of patients underwent colo-rectal surgery at our institution between 1 January 2017 and 31 July 2023

You may qualify if:

• elective setting of surgery
• segmentary left colon surgery including transverse resection, splenic flexure resection and left colectomy even for benign or malign pathology
• days of post-operative follow-up at least available from medical documentation
• primary colo-colic or colo-rectal anastomosis with or without preventing ostomy
• more than 18 years old, less than 90 years old

You may not qualify if:

• terminal colonic stoma without anastomosis creation after demolitive step
• extended transverse right hemicolectomy
• left hemicolectomy with high vascular ligation
• associated bowel or another splanchnic resection (i.e. neoplastic infiltration)
• previous colic surgery
• synchronous neoplasm
• not reporting in operating form details about vascular ligation
• lack in reporting in medical records of primary outcomes
• stage IV cancer
• ASA IV
• less than 18 years old, more then 90 years old
• emergency setting

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

Study Sites (1)

Guglielmo da Saliceto Hospital

Piacenza, 29121, Italy

Location

Related Publications (1)

• Romboli A, Orlandi E, Citterio C, Banchini F, Ribolla M, Palmieri G, Giuffrida M, Luzietti E, Capelli P. Indocyanine green in left side colorectal surgery segmental resection to decrease anastomotic leak: A parallel retrospective cohort study of 115 patients. Heliyon. 2024 Oct 24;10(23):e39730. doi: 10.1016/j.heliyon.2024.e39730. eCollection 2024 Dec 15.

  PMID: 39687188 DERIVED

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andrea Romboli, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: July 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)